small molecule

REXTOVY

NALOXONE HYDROCHLORIDE

Loss of exclusivityMarch 2026FDA regulatory exclusivity expiry
CompanyAmphastar PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameREXTOVY
Active ingredientNALOXONE HYDROCHLORIDE
Strength4MG/SPRAY
Dosage formSPRAY, METERED
RouteNASAL
ModalitySmall molecule
FDA approvalMarch 2023
Marketing statusRX

Regulatory exclusivity

CodeExpires
NPMarch 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

REXTOVY patent cliff — loss of exclusivity March 2026 | CliffBio